Department of Veterans Affairs Network Contracting Office 16 - HOUSTON In Support of the Michael E. DeBakey VA Medical Center (MEDVAMC) REQUEST FOR INFORMATION 36C25619Q0854 BACKGROUND: MEDVAMC has a requirement for the following Genetic Testing: Statement of Work GENERAL: The Michael E. DeBakey VA Medical Center (MEDVAMC) is pursuing a contract with a base year and four (4) one-year options and an emergency six-month extension at the end of the last option year for genetic testing. SCOPE: The MEDVAMC is requesting referral genetic testing for the following list of Test Names and their respective test codes: Test Code Test Name 1300 BLUEPRINT PANEL 1390 TOTAL BLUEPRINT PANEL 1399 WHOLE EXOME SEQUENCING - PROBAND - REFLEX AFTER BLUEPRINT 1500 WHOLE EXOME SEQUENCING - PROBAND 1530 WHOLE EXOME SEQUENCING - PROBAND + CMA 1531 WHOLE EXOME SEQUENCING - PROBAND + COMP MTDNA ANALYSIS 1532 WHOLE EXOME SEQUENCING - TRIO + COMP MTDNA ANLYS 1533 WHOLE EXOME SEQUENCING - TRIO + COMP MTDNA ANLYS - CRITICAL 1580 CUSTOM FAMILY SEQUENCING - GENE 1 1600 WHOLE EXOME SEQUENCING - TRIO 1622 WHOLE EXOME SEQUENCING - TRIO - PRENATAL 1722 WHOLE EXOME SEQUENCING - TRIO - CRITICAL 1800 WHOLE GENOME SEQUENCING - TRIO 2000 MITOMET PLUS ACGH ANALYSIS 2001 OLIGONUCLEOTIDE ACGH ANALYSIS TARGETED ANALYSIS 2085 DUAL GENOME PANEL BY NGS 2090 LOW BONE MASS PANEL BY NGS 2140 PEO PANEL BY NGS 2554 ATP7B - SEQ AND DEL/DUP ANALYSIS 3069 POLG - SEQ AND DEL/DUP ANALYSIS 3200 MITO RESP CHAIN ENZYME ANALYSIS - SKELETAL MUSCLE 3284 LPIN1 - SEQ AND DEL/DUP ANALYSIS 3404 GAA - SEQ AND DEL/DUP ANALYSIS 3600 HEREDITARY PARAGANGLIOMA PHEOCHROMOCYTOMA SYNDROMES PANEL 3660 RET - SEQUENCE ANALYSIS 3665 MEN1 - SEQUENCE ANALYSIS 3740 FH - SEQUENCE ANALYSIS 4100 AMINO ACID ANALYSIS - PLASMA 4200 URINE ORGANIC ACID 4300 PLASMA CARNITINE AND ACYLCARNITINE 4569 HEXA HEXB - ENZYME ANALYSIS - SERUM 6011 GLA - SEQ AND DEL/DUP ANALYSIS 6031 FXN - FRIEDREICH ATAXIA REPEAT EXPANSION ANALYSIS 6034 HTT - HUNTINGTON DISEASE REPEAT EXPANSION ANALYSIS 6035 HFE - MUTATION PANEL 6037 AR - KENNEDY DISEASEE REPEAT EXPANSION ANALYSIS 6041 DMPK - MYOTONIC DYSTROPHY TYPE 1 REPEAT EXPANSION ANALYSIS 6062 THROMBOPHILIA MUTATION PANEL 6085 DMD - FAMILIAL MUTATION/VARIANT ANALYSIS 6087 APC - SEQUENCE ANALYSIS Test Code Test Name 6089 APC - FAMILIAL MUTATION/VARIANT ANALYSIS 6095 MLH1 - SEQUENCE ANALYSIS 6096 MSH2 - SEQUENCE ANALYSIS 6097 MSH6 - SEQUENCE ANALYSIS 6098 HNPCC MSI AND IHC SCREENING 6103 MUTYH - FAMILIAL MUTATION/VARIANT ANALYSIS 6104 MUTYH - MUTATION PANEL 6118 TP53 - SEQUENCE ANALYSIS 6119 TP53 - FAMILIAL MUTATION/VARIANT ANALYSIS 6120 MUTYH - SEQUENCE ANALYSIS 6121 RECQL4 - SEQUENCE ANALYSIS 6122 RECQL4 - FAMILIAL MUTATION/VARIANT ANALYSIS 6142 MLH1 - FAMILIAL MUTATION/VARIANT ANALYSIS 6143 MSH2 - FAMILIAL MUTATION/VARIANT ANALYSIS 6144 MSH6 - FAMILIAL MUTATION/VARIANT ANALYSIS 6376 CFTR - SEQ AND DEL/DUP ANALYSIS 6380 ARSA - SEQUENCE ANALYSIS 6415 GALC - SEQUENCE ANALYSIS 6505 PTEN - SEQUENCE ANALYSIS 6510 PTEN - FAMILIAL MUTATION/VARIANT ANALYSIS 6520 RUNX1 - SEQUENCE ANALYSIS 6525 RUNX1 - FAMILIAL MUTATION/VARIANT ANALYSIS 6573 FMR1 - CGG REPEAT EXPANSION ANALYSIS 6585 COL5A1 - SEQUENCE ANALYSIS 6590 COL5A2 - SEQUENCE ANALYSIS 6640 PMS2 - SEQUENCE ANALYSIS 6641 PMS2 - FAMILIAL MUTATION/VARIANT ANALYSIS 6705 MLH1 - SEQ AND DEL/DUP ANALYSIS 6706 MLH1 - DEL/DUP ANALYSIS 6710 MSH2 - SEQ AND DEL/DUP ANALYSIS 6711 MSH2 - DEL/DUP ANALYSIS 6715 MSH6 - SEQ AND DEL/DUP ANALYSIS 6716 MSH6 - DEL/DUP ANALYSIS 6720 APC - SEQ AND DEL/DUP ANALYSIS 6721 APC - DEL/DUP ANALYSIS 6740 LDLR - SEQ AND DEL/DUP ANALYSIS 6765 VHL - SEQUENCE ANALYSIS 6766 VHL - FAMILIAL MUTATION/VARIANT ANALYSIS 6770 VHL - SEQ AND DEL/DUP ANALYSIS 6775 VHL - DEL/DUP ANALYSIS 6785 PTEN - DEL/DUP ANALYSIS 6790 PTEN - SEQ AND DEL/DUP ANALYSIS 6795 PMS2 - DEL/DUP ANALYSIS 6820 TP53 - DEL/DUP ANALYSIS 6821 TP53 - SEQ AND DEL/DUP ANALYSIS 6888 EPCAM - DELETION ANALYSIS 6890 PMS2 - SEQ AND DEL/DUP ANALYSIS 7521 COL2A1 - SEQ AND DEL/DUP ANALYSIS 8025 ONCOLOGY FISH - ERBB2 (HER2/NEU) 8030 ALK GENE REARRANGEMENT BY FISH ANALYSIS 8031 ONCOLOGY FISH - RET REARRANGEMENT 8035 EGFR FISH ANALYSIS 8050 ONCOLOGY CHROMOSOME ANALYSIS - SOLID TUMOR 8055 1P/19Q CO-DELETION BY FISH - FFPE 8060 1P/19Q CO-DELETION BY FISH - FRESH TISSUE 8065 DXZ1/DYZ3 FISH FOR SEX MISMATCHED BMT 8075 ONCOLOGY FISH - SS18 Test Code Test Name 8080 ONCOLOGY FISH - TCF3/PBX1 FISH for ALL 8085 ClariFind FISH 8095 ONCOLOGY FISH - MET 8300 ONCOLOGY CHROMOSOME ANALYSIS 8385 ONCOLOGY FISH - GAIN 8 CHROMOSOME 8405 CUSTOM FISH 8410 ANEUPLOIDY FISH 8425 RAPID FISH - ANEUVYSION T13 T18 T21 X Y 8426 RAPID FISH ANALYSIS SEX CHROMOSOME X/SRY 8430 FISH ANALYSIS - LANGER GIEDION SYNDROME PANEL EXT1 AND TRPS1 8435 FISH ANALYSIS - MULTIPLE EXOSTOSES PANEL EXT1 AND EXT2 8440 FISH ANALYSIS - DIGEORGE/VELOCARDIOFACIAL SYND 22Q AND 10P 8450 FISH ANALYSIS - WAGR SYNDROME WT1 AND PAX6 8455 FISH ANALYSIS - WILMS WT1 TUMOR 8456 FISH ANALYSIS - 1P36 DELETION SYNDROME 8457 FISH ANALYSIS - ADRENAL HYPOPLASIA CONGENITA 8458 FISH ANALYSIS - ALAGILLE SYNDROME JAG1 RELATED 8459 FISH ANALYSIS - ANGELMAN SYNDROME 8460 FISH ANALYSIS - BECKWITH-WIEDEMANN SYNDROME 8462 FISH ANALYSIS - CHARCOT MARIE TOOTH CMT1A DISEASE 8464 FISH ANALYSIS - CRI DU CHAT SYNDROME 8465 FISH ANALYSIS - DIGEORGE SYNDROME II 10P ONLY 8466 FISH ANALYSIS - GLYCEROL KINASE DEFICIENCY 8467 FISH ANALYSIS - HNPP 8468 FISH ANALYSIS - LIS1 ASSC LSSNCPLY/SBCRTCL BAND HETEROTOPIA 8469 FISH ANALYSIS - KALLMAN SYNDROME TYPE I 8470 FISH-MICROPHTHALMIA WITH LINEAR SKIN LESIONS MLS/MIDAS 8471 FISH ANALYSIS - MILLER-DIEKER SYNDROME 8472 FISH ANALYSIS - MULTIPLE EXOSTOSES 1 EXT1 8473 FISH-MULTIPLE EXOSTOSES 2 / POTOCKI-SHAFFER EXT2 AND ALX4 8474 FISH ANALYSIS - NEUROFIBROMATOSIS 1 8476 FISH ANALYSIS - PRADER-WILLI SYNDROME 8477 FISH ANALYSIS - RUBINSTEIN-TAYBI SYNDROME 8478 FISH ANALYSIS - SMITH-MAGENIS SYNDROME 8479 FISH ANALYSIS - SOTOS SYNDROME 8480 FISH ANALYSIS - SRY ANALYSIS 8482 FISH ANALYSIS - TRICHORHINOPHALANGEAL SYNDROME TYPE I 8483 FISH ANALYSIS - WILLIAMS SYNDROME 8484 FISH ANALYSIS - WOLF-HIRSCHORN SYNDROME 8485 FISH ANALYSIS - X-LINKED ICHTHYOSIS/STS DEFICIENCY 8486 FISH ANALYSIS - DIGEORGE/VELOCARDIOFACIAL SYND TYPE I 22Q 8500 CHROMOSOME ANALYSIS - PRENATAL - AMNIO WITH AFP 8520 CHROMOSOME ANALYSIS - PRENATAL - AFP ACHE FH 8530 CHROMOSOME ANALYSIS - PRENATAL - AMNIOTIC FLUID 8540 CHROMOSOME ANALYSIS - PRENATAL - AMNIO WITH ACHE 8600 CHROMOSOME ANALYSIS - BLOOD 8639 CHROMOSOMAL MICROARRAY ANALYSIS - TISSUE 8655 CHROMOSOMAL MICROARRAY ANALYSIS - HR 8656 TARGETED CMA - PRENATAL DIAGNOSIS - AMNIOTIC FLUID 8657 TARGETED CMA - PRENATAL DIAGNOSIS - CVS 8665 CHROMOSOMAL MICROARRAY ANALYSIS - HR SNP SCREEN 8670 EXPANDED CHROMOSOMAL MICROARRAY ANALYSIS - PRENATAL - AMNIO 8671 EXPANDED CHROMOSOMAL MICROARRAY ANALYSIS - PRENATAL - CVS 8672 CMA TARGETED AND LIMITED KARYOTYPE - PRENATAL - CVS 8673 CMA TARGETED AND LIMITED KARYOTYPE - PRENATAL - AMNIO 8675 CMA EXPANDED AND LIMITED KARYOTYPE - PRENATAL - AMNIO 8676 CMA EXPANDED AND LIMITED KARYOTYPE - PRENATAL - CVS Test Code Test Name 8700 CHROMOSOME ANALYSIS - PRENATAL - CVS 8710 ONCOLOGY FISH - DELETION 5 MDS 8715 ONCOLOGY FISH - DELETION 7 MDS 8720 ONCOLOGY FISH - DELETION 20Q12 MDS 8725 ONCOLOGY FISH - ETO/AML1 T 8 21 AML 8730 ONCOLOGY FISH - CHIC2 DELETED 4Q HYPEREOSINOPHILIC SYNDROME 8735 ONCOLOGY FISH - PML/RARA T 15 17 AML 8740 ONCOLOGY FISH - CBFB INV 16 AML 8745 ONCOLOGY FISH - MLL 11Q24 8750 ONCOLOGY FISH - BCR/ABL t 9 22 CML/ALL/AML 8755 ONCOLOGY FISH - TEL/AMLI T 12 21 ALL 8760 ONCOLOGY FISH - MYC TRANSLOCATION 8765 ONCOLOGY FISH - IGH/BCL2 T 14 18 FOLLICULAR LYMPHOMA 8770 ONCOLOGY FISH - IGH/CCND1 T 14 11 MANTLE CELL LYMPHOMA 8775 ONCOLOGY FISH - BCL6 8780 ONCOLOGY FISH - IGH 8781 ONCOLOGY FISH - ROS1 8785 BCL2 rearrangement 8786 MALT1 lymphoma 8787 non-small cell lung cancer FISH 8788 Oncology FISH Analysis p53 8789 Aggressive high-grade B-cell Lymphoma FISH panel 8840 TISSUE CULTURE AND FREEZE BACK 8972 BCR-ABL1 minor (p190) Quantitative 8975 PD-L1 22C3 IHC for NSCLC by immunohistochemistry with interpretation. Pembrolizumab (KEYTRUDA) 8976 PD-L1 28-8 pharmDx IHC w/ interpretation. Nivolumab 8977 PD-L1 22C3 IHC with combined positive score (CPS) interpretation. Pembrolizumab (KEYTRUDA) 9003 BRAF V600E MUTATION DETECTION IN HAIRY CELL LEUKEMIA 9005 NPM1 MUTATION BY PCR AND FRAGMENT ANALYSIS 9010 JAK2 GENE, V617F MUTATION, QUALITATIVE 9015 JAK2 EXON 12 MUTATION ANALYSIS BY PCR 9016 CALR (CALRETICULIN) EXON 9 MUTATION ANALYSIS BY PCR 9020 MPL CODON 515 MUT DETECT BY PYROSEQUENCING, QUANT 9030 EGFR MUTATION DETECTION BY PYROSEQUENCING 9045 FLT3 - MUTATION ANALYSIS 9055 TP53 SOMATIC MUTATION, PROGNOSTIC 9057 TP53 - TARGETED MUTATION ANALYSIS - GERMLINE 9060 IGHV MUTATION ANALYSIS BY SEQUENCING 9065 BCR-ABL1, MAJOR (P210), QUANTITATIVE 9070 BCR-ABL1, QUALITATIVE WITH REFLEX TO BCR-ABL1 QUANTITATIVE 9080 PML-RARA TRANSLOCATION, T(15;17) BY RT-PCR, QUANTITATIVE 9086 CEBPA Mutation Detection 9103 KIT MUTATIONS, MELANOMA 9104 GASTROINTESTINAL STROMAL TUMOR MUTATION 9105 KIT MUTATIONS IN AML BY FRAGMENT ANALYSIS AND SEQUENCING 9128 KRAS MUTATION DETECTION 9150 MICROSATELLITE INSTABILITY MSI, HNPCC/LYNCH SYNDROME, BY PCR 9202 B-CELL CLONALITY SCREENING (IGH AND IGK) BY PCR 9217 COMPREHENSIVE T-CELL CLONALITY ANALYSIS 9305 BCR-ABL1 MUT ANALYS TYROSINE KINASE INHIBITOR RESISTANCE NGS 9505 CANCER CHROMOSOMAL MICROARRAY ANALYSIS - 180K CGH/SNP ARRAY 9515 CYTOSCAN HD SNP ARRAY - TUMOR 9705 SOLID TUMOR MUTATION PANEL 20004 HEREDITARY CANCER PANEL COMPREHENSIVE 20010 ClariFind Comprehensive DNA Panel 20640 MTHFR - GENE SEQUENCING BY NGS Test Code Test Name 22304 HEREDITARY BRAIN CNS PNS CANCER PANEL 22335 PHOX2B - GENE SEQUENCING BY NGS 22350 BRCA1/BRCA2 - SEQ AND DEL/DUP ANALYSIS 22404 HEREDITARY BREAST/OVARIAN/ENDOMETRIAL CANCER PANEL 22504 HEREDITARY RENAL CANCER PANEL BY NGS 22505 CDKN1C - GENE SEQUENCING BY NGS 22510 FLCN - GENE SEQUENCING BY NGS 22604 HEREDITARY ENDOCRINE CANCER PANEL BY NGS 22704 HEREDITARY LEUKEMIA/LYMPHOMA PANEL BY NGS 22804 HEREDITARY COLORECTAL/GASTROINTESTINAL CANCER PANEL 22820 ENG - GENE SEQUENCING BY NGS 22904 HEREDITARY MELANOMA PANEL BY NGS 23000 HEREDITARY BREAST CANCER PANEL HIGH RISK 23104 HEREDITARY PARAGANGLIOMA/PHEOCHROMOCYTOMA PANEL 23204 HEREDITARY COLORECTAL CANCER PANEL HIGH RISK 23304 HEREDITARY PANCREATIC CANCER PANEL BY NGS 23404 HEREDITARY PROSTATE CANCER PANEL BY NGS 24000 COMMON HEREDITARY CANCER PANEL (27 genes) 29271 NDP - FAMILIAL MUTATION/VARIANT ANALYSIS 60101 GENEAWARE COMPLETE FEMALE V2 60106 GENEAWARE COMPLETE MALE V2 60201 GENEAWARE ASHKENAZI JEWISH FEMALE V2 60206 GENEAWARE ASHKENAZI JEWISH MALE V2 60301 GENEAWARE ACMG/ACOG FEMALE V2 60306 GENEAWARE ACMG/ACOG MALE V2 60401 GENEAWARE BASIC FEMALE V2 60406 GENEAWARE BASIC MALE V2 The contractor shall provide and ensure safe, secure, and careful handling of the patient samples and the reporting of results in accordance with established guidelines from the Department of Veterans Affairs Handbook 6500, the College of American Pathologists (CAP), the Joint Commission on Accreditation of Health Care Organizations (JCAHO), guidelines established by VA Laboratory Service or as required to follow the Health Insurance Portability and Accountability Act of 1996 (HIPAA) during transportation. PERIOD OF PERFORMANCE: Base Period: Oct. 1, 2019 to Sept. 30, 2020 Option Year 1: Oct. 1, 2020 to Sept. 30, 2021 Option Year 2: Oct. 1, 2021 to Sept. 30, 2022 Option Year 3: Oct. 1, 2022 to Sept. 30, 2023 Option Year 4: Oct. 1, 2023 to Sept. 30, 2024 GOVERNMENT S RESPONSIBILITY: They send out laboratory personnel at the MEDVAMC will affix a label containing the patient s full name and full social security number to the specimen s container in order to ensure integrity of the information, place the specimen (that is being sent for processing) in a sealed tamper evident container and prepare it for pickup. The MEDVAMC will then call the contractor to arrange immediate pickup and direct delivery to the Genetics testing Lab. REQUESTED RESPONSES: The intent of this Request for Information is to establish sources to define the procurement strategy (e.g set-aside, sole source, unrestricted) for a solicitation that VA intends to post soon. Interested contractors are requested to respond in accordance with the following: Please respond to this RFI if you can provide the exact brand name products listed in the table in the background section above. In the response please cite your business size status. If you have an existing GSA or VA, Federal Supply Schedule contract, please include the contract details in your response. DISTRIBUTORS: You must provide proof that you are an authorized distributor. VA does not accept grey market items. Please respond to this RFI if you can provide supplies that may be determined EQUIVALENT to the products listed in the table in the background section above. Please provide details on the proposed EQUIVALENT products such as Manufacturer Name, Part Number, and Description. If you have an existing GSA or VA, Federal Supply Schedule contract, please include the contract details in your response. DISTRIBUTORS: You must provide proof that you are an authorized distributor. VA does not accept grey market items. Please note that VA is particularly interested in determining the availability of Small Business Manufacturers. If your company is a small business manufacturer of potentially equivalent items, please respond to this RFI. Vendors are requested to submit estimated market research pricing with their responses. The estimated pricing will be considered when determining the procurement strategy for the future solicitation. (e.g. if CO determines that capable small businesses cannot provide fair and reasonable pricing, then the solicitation will not be set-aside). Please note that if no responses to this notice are received, from either authorized distributors of the cited brand name nor from manufacturers marketing a potentially equivalent brand, then this action will be sole sourced to the manufacturer cited in the Background section above. CONTACT INFORMATION AND RESPONSE DUE DATE: Please email all responses to [email protected]. Please respond to this RFI no later than May 21, 2019. DISCLAIMER: This RFI is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI.

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